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FDA’s Efforts to Facilitate Antibiotic Approvals

Remarks as Delivered of Margaret A. Hamburg, M.D. Commissioner of Food and Drugs IDSA World Health Day Event April 7, 2011

Good morning—I’d like to thank the Infectious Diseases Society of America for inviting me to be part of this important event focused on such a critical and urgent public health issue and for the work they do every day to combat infectious disease threats and to improve health.

The problem of antimicrobial resistance is one in which we all have a stake—both professionally and personally. And we worry with good cause: today, antibiotic-resistance mechanisms have been reported for virtually all known antibacterial drugs available for clinical use—and, as Dr. Hughes said, it is more than just hypothetical to talk about a about a return to a “pre-antibiotic era” in which we no longer have effective tools to treat serious infectious disease. We have no room for complacency. This threat affects everything from ear infections in school children to global infectious diseases…and the consequences can be tragic.

Unfortunately, one of today’s speakers, Theresa Drew, knows that all too well. Theresa: thank you for being here today, and for bravely sharing your son’s story with us. We are all here today because we want to make sure that what happened to Ricky galvanizes us to action and helps the same thing from happening to other children all over the world.

Early in my own career, when I served as Commissioner of the New York City Department of Health and Mental Hygiene, I saw the damage that drug-resistant tuberculosis could do to a city’s population. In 1991, when I took the job, New York City reported the highest TB case rate in almost three decades.

TB is an intrinsically treatable and controllable disease, yet it had reached epidemic proportions, with startlingly high levels of drug resistant forms that were much more difficult to treat and cure effectively. It took a well-designed program, adequate resources, and real political and program commitment from the Mayor and others, but we managed, after only a few years, to reduce the number of drug-resistant TB cases by 86 percent.

Of course, that effort represents only a small piece of a much larger puzzle—but it convinced me that we can make a difference, and secured my commitment to continuing efforts to help find solutions for so many other diseases and millions of people.

But we must take action now. We live in a time of incredible breakthroughs in science and technology—advances that could be transformative for people and medical progress alike. Yet the sad irony is: we are facing a situation in which tried and true antibacterial drugs are losing their value at the same time as the new-drug pipeline is distressingly devoid of innovative candidate drugs.

This is completely unacceptable…and the Food and Drug Administration can and must play an important role in addressing this concern. We are fully committed to working with all of you to find creative new solutions to the problem of antimicrobial resistance.

To be successful, we must address this problem from many sides. Microorganisms constantly evolve and are likely to grow resistant to any new drugs we develop. This poses a continuous challenge and demands long-term solutions.

Fundamentally, we must focus on preserving the drugs we have. This means educating patients and healthcare providers about judicious use of existing antibiotics through rational prescribing, and better patient compliance, as well as in food animal production. And we must work to ensure more appropriate treatment through better use of diagnostics, to guide appropriate use, and to support quality infection control procedures to reduce the spread of resistant organisms.

But even if we improve these practices, resistant bacteria will emerge and persist. Which means, no matter what, we need to develop new drugs. Unfortunately, the number of newly approved antibiotics—not just new formulations of previously existing drugs—has fallen steadily since the 1980s. And the range of new antibiotics is disturbingly limited in terms of the types or classes of antibiotics available and the diseases they can treat.

Naturally, there are complex reasons why we are not seeing more products in the pipeline. And we will only find meaningful solutions by understanding and systematically addressing the many aspects—and challenges—of the problem.

For example, there are economic challenges. Specifically, the limited market of new antibiotics and their short-term use can contribute to an inherent conflict between companies’ desire for widespread use of their products and the public health need for careful and limited use. This has led to important discussions of the types of economic policies and incentives that recognize the unique value of these products, helping to encourage new antibiotic development and strengthen the pipeline for these vitally needed tools.

Another key challenge is the need to build on advances in science and harness them into focused research and development efforts in a number of critical arenas—for instance, to develop antibiotics that act via new mechanisms that reflect our best understanding of potential drug targets, disease pathogenesis, and human immune response.

We must also support expanded research in microbiology and epidemiology and conduct surveillance to better understand and detect the emergence of new strains as early as possible. We must develop new vaccines that have the potential to reduce the incidence of disease, diminishing the need for antimicrobial treatment in the first place. And we must develop better diagnostics—including new point of care rapid diagnostics—that will help curb overuse of antibiotics by allowing physicians to determine the nature of a patient’s infection as well as potential resistance patterns.

Finally, we need better, more advanced strategies for evaluating the effectiveness of new antimicrobials once they are in development. This includes new clinical trial designs that reflect the need for important and robust scientific answers but are realistic about constraints, such as the number of patients, the size and length of studies, and the cost of the trials.

And at FDA, we will also continue efforts to streamline and modernize our regulatory pathways so that we can expeditiously review applications for new antimicrobial drugs, diagnostics, and vaccines when they come before us.

The truth is we have made important progress over the last several years, but there is a lot more that needs to be done—and, quite frankly, we have a difficult road ahead.

We are confronting extremely complex scientific issues but, working with industry and the infectious disease community, we are continually striving for the goal of establishing better, more transparent, more predictable pathways for studying these vital medical products.

Importantly, scientists at FDA have been working hard to develop clinical trial recommendations that are scientifically sound, ethical, and feasible, as well as to provide updated guidances for industry.

Several important guidances that are currently underway and considered top priorities based on patient need include guidances on Complicated Urinary Tract Infections, Complicated Intra-abdominal Infections, and Serious Bacterial Infections with Unmet Need, as well as an Updated Draft Guidance on Community-Acquired Bacterial Pneumonia. We anticipate that these will be complete by late this year.

I also want to take this opportunity to recognize the great work that is being led by the Foundation for the National Institutes of Health. The FNIH has provided a valuable forum for scientists from academia, industry, IDSA, NIH, and FDA to work together to develop new endpoints that will enable clinical trials of new antibacterial drugs.

This is an important effort that will help further develop the science of clinical trials for antibacterial drugs for skin infections and community-acquired pneumonia—and I look forward to the outcome. I also want to express my gratitude to all of those who have rolled up their sleeves and contributed to the work on new endpoints and new pathways for studying antibacterial drugs. This is such an essential and timely area of work.

It goes without saying that we cannot do any of this alone, so, as we move forward, we will solicit the input and the partnership of various groups of stakeholders. We have been—and will continue to be—open about these challenges at various public workshops and at advisory committees that seek outside opinions on paths forward for drug development.

And we will continue to collaborate with our partners within the government—such as the Centers for Disease Control and Prevention, the U.S. Department of Agriculture, and the National Institutes of Health. In this regard, I am very pleased that last month, the revised version of the Public Health Action Plan to Combat Antimicrobial Resistance was published for comment. The Plan provides a valuable framework for us to work with our Federal Partners on the issue of antimicrobial resistance…and we welcome feedback on how we can strengthen these efforts to make them as effective as possible.

And events like this one are a vital contribution. We need to come together to bring renewed attention and commitment to bear on this very real and growing problem. I hope that by joining hands and sharing ideas, we will be able to find solutions for Ricky and for all the others who have suffered the consequences of antimicrobial resistance, in this country and throughout the world.